Indirect Inguinal HerniaNCT01211067
Study of Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia
An observational study of Indirect Inguinal Hernia, run by Cirujanos la Serena at 2 sites in Chile.
Trial summary
The histology of the internal inguinal ring in patients with indirect hernia submitted to elective surgery was studied. In contrast with recently published studies, the investigators believe that histological findings of the internal inguinal ring would reflect those associated and expected with normal aging. Read more about this study
- Who is it for?
- Ages 15 years and older, men only
- Conditions the study is for
- Indirect Inguinal Hernia
- What is being tested?
- Lichtenstein hernioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 2 sitesChile
- Study dates
- Sep 2009to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with indirect inguinal hernia submitted to elective surgery with the Lichtenstein hernioplasty technique
Who may be able to join
- Male gender
- Older than 15 years-of-age
- Unilateral indirect inguinal hernia
- Non-smokers
- Non-diabetics
- Non-connective tissue conditions
- Primary inguinal hernia
Who cannot join
- Female gender
- Younger than 15 years-of-age
- Bilateral inguinal hernia
- Direct or combined direct-indirect inguinal hernia
- Femoral hernia
- Smokers
Show all 9Show fewer
- Diabetics
- Other connective tissue diseases
- Recurrent inguinal hernia
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Hospital de La Serena
La Serena, Coquimbo Region, IV REGION
Hospital de La Serena
La Serena, Coquimbo Region
About this study
Official title: Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia
The histology of the internal inguinal ring in patients with indirect hernia submitted to elective surgery was studied. In contrast with recently published studies, the investigators believe that histological findings of the internal inguinal ring would reflect those associated and expected with normal aging.
- Conditions
- Indirect Inguinal Hernia
- Being tested
- Lichtenstein hernioplasty
- Keywords
- Inguinal hernia, Inguinal ring, Histology, Hernioplasty, Lichtenstein
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein hernioplastyProcedure or surgery
- Mesh hernioplasty
- Ultrapro mesh (Ethicon, Johnson \& Johnson)
| Study group | Role | What they receive |
|---|---|---|
| Patients age: 15 - 40 years-old | Patients within the 15 to 40 years-old age-group Receives: Procedure: Lichtenstein hernioplasty | |
| Patients age: 41 to 60 years-old | Patients within the group-age from 41 to 60 years-old Receives: Procedure: Lichtenstein hernioplasty | |
| Patients age: older than 61 years-old | Patients within the group-age from 61 years-old and older Receives: Procedure: Lichtenstein hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histology of the internal inguinal ring
Histology and histological findings of the internal inguinal ring in patients submitted to elective surgical reparation of an indirect inguinal hernia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Indirect Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cirujanos la Serena
- Sponsor type
- University, hospital or other
- Investigators
- Marcelo A Beltrán, M.D., Principal investigator, Hospital de La Serena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211067
- Sponsor's protocol ID
- HLS-0015-1109
- Status last verified
- Sep 2010
- First submitted
- 28 Sep 2010
- Last updated
- 29 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Barria C, Beltran MA, Contreras MA, Cruces KS. Histology of the internal inguinal ring: it is really a novelty? Hernia. 2010 Jun;14(3):339-40. doi: 10.1007/s10029-010-0661-4. Epub 2010 May 1. No abstract available.
PubMed 20437189
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia
- ClinicalTrials.gov ID
- NCT01211067
- Acronym / sponsor ID
- HLS-0015-1109
- Conditions
- Indirect Inguinal Hernia
- Keywords
- Inguinal hernia, Inguinal ring, Histology, Hernioplasty, Lichtenstein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cirujanos la SerenaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 29 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The histology of the internal inguinal ring in patients with indirect hernia submitted to elective surgery was studied. In contrast with recently published studies, the investigators believe that histological findings of the internal inguinal ring would reflect those associated and expected with normal aging.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients age: 15 - 40 years-old | – | Procedure: Lichtenstein hernioplastyPatients within the 15 to 40 years-old age-group |
| Patients age: 41 to 60 years-old | – | Procedure: Lichtenstein hernioplastyPatients within the group-age from 41 to 60 years-old |
| Patients age: older than 61 years-old | – | Procedure: Lichtenstein hernioplastyPatients within the group-age from 61 years-old and older |
Who may qualify
- Ages
- 15 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with indirect inguinal hernia submitted to elective surgery with the Lichtenstein hernioplasty technique
Key inclusion criteria (7 listed)
- Male gender
- Older than 15 years-of-age
- Unilateral indirect inguinal hernia
- Non-smokers
- Non-diabetics
Key exclusion criteria (9 listed)
- Female gender
- Younger than 15 years-of-age
- Bilateral inguinal hernia
- Direct or combined direct-indirect inguinal hernia
- Femoral hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lichtenstein hernioplasty* Mesh hernioplasty * Ultrapro mesh (Ethicon, Johnson \& Johnson) | Procedure or surgery | Patients age: 15 - 40 years-old, Patients age: 41 to 60 years-old, Patients age: older than 61 years-old |
Primary outcome
Histology of the internal inguinal ring
Time frame: 6 months
Histology and histological findings of the internal inguinal ring in patients submitted to elective surgical reparation of an indirect inguinal hernia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2010.
- Background: PubMed 20437189Barria C, Beltran MA, Contreras MA, Cruces KS. Histology of the internal inguinal ring: it is really a novelty? Hernia. 2010 Jun;14(3):339-40. doi: 10.1007/s10029-010-0661-4. Epub 2010 May 1. No abstract available.
Related trials for Indirect Inguinal Hernia
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Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
Indirect Inguinal Hernia
Active, not recruitingObservational study
INVESTIGATION OF THE GENETIC ETIOLOGY OF HERNIA SAC DEVELOPMENT IN MALE CHILDREN WITH UNDESCENDED TESTIS AND INGUINAL HERNIA
Indirect Inguinal Hernia, Undescended Testis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo A Beltrán, M.D. principal investigator
Hospital de La Serena
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indirect Inguinal Hernia, run by Cirujanos la Serena at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histology of the internal inguinal ring (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01211067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2010.